대한뉴팜

Daehan Nupharm held a groundbreaking and safety prayer ceremony on October 17 for the construction of a new GMP production facility at its Hyangnam plant site, marking a major step toward strengthening its global manufacturing competitiveness. The new facility will involve an investment of KRW 42.9 billion and will cover a total floor area of 15,123 m², consisting of one basement level and five above-ground floors. Construction is scheduled to take 15 months, followed by a validation period, with full-scale production beginning in 2027. This initiative is part of the company’s long-term strategy to build future growth engines. In 2021, Daehan Nupharm opened its Industry-Academia-Research Center to enhance R&D capabilities. Since 2022, the company has strategically advanced the “Hyangnam Project 1·2·3.” Phase 1: Completion of the R&D center in May 2023. Phase 2: Groundbreaking of the new GMP plant, following concept design and detailed engineering. Phase 3: Planned construction of an automated logistics warehouse. The new plant will be equipped with state-of-the-art injection and solid dosage production lines, as well as storage facilities. The injection area will include two vial lines, a lyophilization line, and an ampoule line that incorporate CIP/SIP systems and PUPSIT to ensure aseptic manufacturing. The solid dosage area will feature a BIN system to minimize contamination, with a production capacity of up to 800 million tablets annually. Korea has strengthened its pharmaceutical quality and export competitiveness since joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2014. In December 2023, the Ministry of Food and Drug Safety (MFDS) revised its GMP regulations to mandate contamination control strategies for sterile products. The construction of Daehan Nupharm’s new plant fully complies with these global regulatory standards, positioning the company to further enhance its export capabilities. As the largest investment in the company’s history, this new facility has been carefully planned from the design stage to optimize operational efficiency. Beyond increasing production capacity, Daehan Nupharm aims to secure a stable supply of high-quality pharmaceuticals, expand global exports, and advance R&D initiatives—paving the way to become a leading global pharmaceutical and biotech company.

Daehan Nupharm recorded KRW 48.3 billion in sales, KRW 4.5 billion in operating profit, and KRW 5.2 billion in net profit for the first quarter of 2024. Following last year’s record-high annual sales of KRW 204.2 billion, the company achieved solid performance driven by strong sales in its core pharmaceutical business. In particular, the newly launched Rapiduo Tab. and well-being injection products have contributed significantly to sales growth. Rapiduo Tab., launched in March, is a treatment for gastroesophageal reflux disease (GERD). It is an improved new drug that combines rabeprazole (PPI) and magnesium oxide, a first-of-its-kind formulation, which reaches maximum plasma concentration within one hour after administration, overcoming the limitation of existing PPI formulations that take 6 to 7 hours to take effect. To expand its growth base, the company is further strengthening R&D efforts across its business divisions, including pharmaceuticals, veterinary medicine, biotechnology, and health functional foods. In addition to Rapiduo Tab., active research is underway on improved combination drugs for hypertension, hyperlipidemia, and obesity. In the veterinary medicine sector, the company is developing various products for both livestock and companion animals. Recently, Daehan Nupharm received regulatory approval for DH Fuzole Tab., a fluconazole-based treatment specifically for Malassezia dermatitis in companion dogs. The company is also pursuing the construction of a new production facility to support future growth. In addition to investing in R&D, Daehan Nupharm plans to ensure a stable supply of high-quality pharmaceuticals through the new plant, establishing a solid foundation to further increase sales in human pharmaceuticals.

Daehan Nupharm recorded KRW 204.2 billion in annual sales for 2023, achieving its highest sales performance to date, along with KRW 18.8 billion in operating profit and KRW 12.5 billion in net profit. The company continues to focus on product research and development across its key business divisions—pharmaceuticals, veterinary medicine, biotechnology, and health functional foods. In addition to the recently launched Rapiduo Tab., R&D efforts are actively underway for improved combination drugs for hypertension, hyperlipidemia, and obesity treatment.In the veterinary medicine division, Daehan Nupharm is expanding its portfolio to cover a wide range of products for both livestock and companion animals. Notably, the company recently received regulatory approval for DH Fuzole Tab., a fluconazole-based treatment for Malassezia dermatitis in dogs. Currently, most antifungal agents prescribed in domestic animal hospitals are human medications. Although fungal skin diseases, including Malassezia infections, are common in companion animals, there has been a lack of approved veterinary drugs, highlighting the need for safe and effective animal-specific antifungal treatments. Daehan Nupharm plans to continuously introduce new products that meet veterinarians’ clinical needs. Through ongoing research and development, the company has successfully developed DH Fuzole Tab. as a veterinary medicine based on its existing human formulation. By pursuing R&D strategies that create synergy across business divisions, Daehan Nupharm aims to launch innovative products and maintain sustainable growth.

Daehan Nupharm’s health functional food brand “DiNU” has launched a new inner beauty product, “DiNU Core Collagen.”Unlike conventional collagen products made from tilapia, pangasius, or other freshwater fish scales and skin, DiNU Core Collagen is manufactured using tuna sourced from clean, open seas through an eco-friendly patented process that eliminates chemical treatments such as acid and alkali processing. The product uses low-molecular-weight collagen produced domestically, setting it apart from existing collagen supplements. A key feature of DiNU Core Collagen is that it is made with Korea’s only tuna-derived collagen, developed in collaboration with a domestic university, and that the entire production process—from raw material to finished product—is carried out in Korea. Building on the successful market entry of “DiNU Paraotics,” a patented double-capsule probiotic product, Daehan Nupharm is leveraging its expertise in obesity and wellness to develop differentiated health functional foods that combine unique raw materials and advanced technology.

Daehan Nupharm announced that it has received marketing authorization from the Ministry of Food and Drug Safety (MFDS) for its new gastroesophageal reflux disease (GERD) treatment, “Rapiduo Tab.” As part of its transformation into a research-driven pharmaceutical and biotech company, the firm is focusing on the development of both incremental and innovative new drugs. Rapiduo Tab is one of the company’s key pipeline products and represents a novel combination of rabeprazole (a proton pump inhibitor, PPI) and an antacid.Rabeprazole is chemically unstable in acidic environments and rapidly degrades in gastric acid. To address this, Rapiduo Tab combines rabeprazole with magnesium oxide for the first time, allowing magnesium oxide to neutralize gastric acid and raise intragastric pH, thereby protecting rabeprazole from degradation and enabling rapid absorption. This results in faster acid suppression compared to existing therapies. Rapiduo Tab demonstrated a Tmax of less than one hour after administration, confirming superior acid control versus reference products. It also applies dual-core tablet technology to reduce tablet size and improve patient compliance. Rapiduo Tab 10/350 mg is scheduled for launch in March 2024, while the 20/350 mg high-dose formulation is planned for release in the second half of 2024. Daehan Nupharm continues to expand its incremental drug development efforts across both the gastroenterology and cardiovascular therapeutic areas.

Daehan Nupharm announced that its cumulative sales for the third quarter of 2023 reached KRW 153.6 billion, representing a 3.9% increase year-on-year. Cumulative operating profit came to KRW 18.1 billion, with an operating profit margin of 11.8%. The company is steadily progressing toward its annual sales target of KRW 200 billion and plans to further expand R&D investment to strengthen future growth drivers. Daehan Nupharm intends to focus on incremental drug development for prescription pharmaceuticals, while also enhancing dosing convenience through the development of new formulations for diabetes and obesity treatments. Strong growth in injectable products, one of the company’s core business strengths, continues to drive sales. In particular, wellness injections such as Vitamin C Injection and Luthione Injection are posting sustained growth. Sales of Liporase Injection, which contains hyaluronidase, are expected to exceed KRW 9 billion this year. The company’s health functional food segment is also showing steady growth. Daehan Nupharm plans to launch a differentiated collagen product in December, further diversifying its portfolio.

Daehan Nupharm announced that its sales for the first half of 2023 reached KRW 104.4 billion, an 8.6% increase compared to the same period last year. Operating profit was recorded at KRW 12.9 billion. Income before income taxes came to KRW 14.8 billion, and net income was KRW 10.9 billion, representing a decrease of 25.5% and 27.1%, respectively, year-on-year. However, excluding the KRW 8.9 billion reversal of litigation provisions recorded in the previous year, income before income taxes from continuing operations was KRW 10.9 billion and net income was KRW 8.1 billion, reflecting a 35.2% and 32.2% increase compared to the same period last year. The company expects steady sales growth in the second half of the year, supported by planned new product launches and a strengthened R&D pipeline. In addition, Daehan Nupharm plans to expand investment in infrastructure and R&D to enhance its mid- to long-term competitiveness.

Daehan Nupharm has signed a mutual cooperation agreement with Professor Peter Namsoo Kim, a leading authority in hemp research, to conduct the nation’s first joint research on the production of standardized hemp materials.Professor Kim previously served as a professor at Texas State University and is currently a Distinguished Invited Scientist at the Gyeongbuk Institute for Bioindustry, where he leads the Hemp Research Forum.Through this agreement, Daehan Nupharm will apply Professor Kim’s patented domestic technologies and a U.S. patent-pending PK-16 analytical method to pursue GMP production of standardized hemp materials in Korea. Using the PK-16 method, the company will analyze more than 16 microcomponents from locally cultivated hemp and utilize these results to conduct animal testing in Korea and clinical trials in Thailand.This joint research will be carried out in conjunction with Daehan Nupharm’s GMP production facilities in line with ongoing efforts to legalize hemp domestically. The project is expected to serve as a foundation for Korea’s hemp industry. Through this research, the company aims to develop core technologies that expand the application of medical hemp globally and to establish a successful case of convergence research between science and clinical practice.

Daehan Nupharm is expanding the supply of its antivenom product and varicella (chickenpox) vaccine. In November last year, the company signed an agreement with Boran Pharma to launch Korea’s only treatment for pit viper bites, the antivenom injection. In December, it began sales of the country’s first introduced varicella vaccine, and starting this month, it has begun offering the Japanese encephalitis live vaccine.The Boran Dried Pit Viper Antivenom Injection is the only snake venom antidote available in Korea. Upon injection, it rapidly neutralizes venom toxins through antigen-antibody binding, significantly reducing venom concentration within one hour of administration. Particularly, about 44% of snakebite cases reported in autumn are severe. To address this, Daehan Nupharm supplies antivenom to emergency medical institutions to enable prompt treatment of life-threatening acute intoxication.The Variel Vaccine is Korea’s first varicella vaccine and an attenuated live vaccine based on the Oka strain, which represents the most common genotype of varicella-zoster virus (VZV). As one of the National Immunization Program (NIP) vaccines, it is the only varicella vaccine in Korea that can be administered to adolescents and adults as well as children, with no age restrictions.The CDJEVAX Japanese Encephalitis Live Vaccine, launching this month, is the only live vaccine included in the National Immunization Program. Approved in 1989, it has been administered to over 200 million people worldwide over a ten-year period. It was the first vaccine for children to receive WHO Prequalification (PQ) and has demonstrated safety through studies involving more than one million children, showing minimal adverse reactions. With a two-dose regimen providing over 95% preventive efficacy, it offers greater dosing convenience compared to vaccines requiring five doses.This year, Daehan Nupharm aims to expand distribution of these three products and stabilize their market presence, with a goal of achieving combined sales exceeding KRW 5 billion by 2027. The company also plans to strengthen partnerships and advance joint research and development initiatives to ensure sustainable growth.